Hepatitis B MedDRA version: 7.1 Level: LLT Classification code 10019731
Conditions
Interventions
Product Name: Hepatitis B Vaccine (Recombinant) Upgraded Process
Product Code: HBV-UP
Pharmaceutical Form: Suspension for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concen
Sponsors
Merck SHARP & DOHME DE ESPAÑA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Healthy male and female children 4 to 6 years of age ? Complete medical records documenting the administration of a 3-dose series of HBVAXPRO™ or ENGERIX-B™ administered according to one of the following schedules: birth, 1, and 6 months of age; birth, 2, and 6 months of age; or 2, 4, and 6 months of age (for Cohorts A and B only). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Birth mother known to be a carrier of hepatitis B virus (HbsAg+) or known carriers ever living in close contact with the subject ? History of previous hepatitis B infection ? History of vaccination with any hepatitis B vaccine (Cohort C only) ? History of any hepatitis B vaccination after copmletion of he 3-dose primary series (Cohorts A and B only) ? A combination of different hepatitis B vaccines used in the primary vaccination series (Cohorts A and B only) ? Recent (<72 hours) history of febrile illness (oral temperature =37.8°C [=100.0°F]) ? Known or suspected hypersensitivity to any component of HBVAXPRO™ or ENGERIX-B™ (e.g., aluminum, yeast) ? Recent administration (within 3 months prior to study start) of hepatitis B immune globulin, or any other blood-derived product (excluding autologous product) ? Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To assess the quality of the priming of HBVAXPRO™ by demonstrating acceptability of the anamnestic response after a booster dose (of either modified process hepatitis B vaccine or ENGERIX B™) in healthy children 4 to 6 years of age. ? To determine the ability of subjects to mount an anamnestic immune response to either HBVAXPRO™ or ENGERIX-B™ ? To assess the safety and tolerability of a booster dose of a modified process hepatitis B vaccine in healthy children 4 to 6 years of age ;Secondary Objective: ? To characterize the ability of modified process hepatitis B vaccine to act as a booster dose;Primary end point(s): ? 4-week postvaccination SPR (defined as an anti-HBs titer =10 mIU/mL) ? Safety | — |
Countries
Spain
Outcome results
None listed